Background of the Invention
[0001] Stents are placed or implanted within a variety of bodily vessels including in coronary
arteries, renal arteries, peripheral arteries including illiac arteries, arteries
of the neck and cerebral arteries, veins, biliary ducts, urethras, fallopian tubes,
bronchial tubes, the trachea, the esophagus and the prostate.
[0002] Stents are available in a wide range of designs. One popular stent design includes
a plurality of serpentine rings having alternating peaks and troughs. Adjacent rings
are interconnected via connecting elements. If adjacent rings are spaced too close
together, however, binding, overlapping or interference can occur between adjacent
rings on the inside of a bend due to the facing peaks and troughs moving toward each
other and into contact.
[0003] There remains a need for innovative, flexible stents which are designed so that interference
between adjacent rings does not substantially occur.
[0004] Without limiting the scope of the invention a brief summary of some of the claimed
embodiments of the invention is set forth below. Additional details of the summarized
embodiments of the invention and/or additional embodiments of the invention may be
found in the Detailed Description of the Invention below.
From
WO 00/30563 A1, which is regarded as the closest prior art, a longitudinally flexible expandable
stent is known. The segmented stent of open structure is comprised of end-connected
struts of first and second lengths making up a first and a second segment with angular
interconnections between adjacent first and second segments.
[0005] Further, from
WO 02/060344 A1 a flexible and expandable stent is known. The stent comprises a first undulating
band comprising a series of alternating first peaks and first troughs and a second
undulating band comprising a series of alternating second peaks and second troughs.
A plurality of longitudinally oriented first connectors extends between the first
peaks and second peaks.
Summary of the Invention
[0006] In one embodiment, the invention is directed to a stent comprising at least two serpentine
circumferential bands including a first serpentine circumferential band and a second
serpentine circumferential band. Each serpentine circumferential band has alternating
peaks and troughs. There is a plurality of unconnected peak-trough pairs with each
unconnected peak-trough pair comprising a peak on the first serpentine circumferential
band and a trough on the second serpentine circumferential band which is substantially
circumferentially aligned with the peak when the stent is in an unexpanded configuration
and desirably when it is in a delivery configuration on a catheter. The trough is
not connected to the peak. There also is a plurality of connected peak-trough pairs
with each connected peak-trough pair comprising a peak on the first serpentine circumferential
band and a trough on the second serpentine circumferential band which is substantially
circumferentially aligned with the peak when the stent is in an unexpanded configuration
and desirably when it is in a delivery configuration on a catheter. The trough is
connected to the peak. The distance along the first serpentine circumferential band
between each peak of a connected peak-trough pair and an adjacent peak of an unconnected
peak-trough pair differs from the distance along the second serpentine circumferential
band between the trough of the connected-trough pair and an adjacent trough of an
unconnected peak-trough pair, the adjacent peak substantially opposite the adjacent
trough. As the stent expands, peaks and troughs of unconnected peak-trough pairs are
displaced relative to one another about the circumference of the stent.
[0007] Desirably, the first and second serpentine circumferential bands are connected to
one another via a plurality of longitudinal connectors.
[0008] Typically, the stent will have three or more of the serpentine circumferential bands,
adjacent serpentine circumferential bands connected one to the other. There will be
a plurality of unconnected peak-trough pairs along adjacent serpentine circumferential
bands, each unconnected peak-trough pair comprising a peak on one serpentine circumferential
band and a trough on the adjacent serpentine circumferential band which is substantially
circumferentially aligned with the peak when the stent is in an unexpanded configuration,
and desirably in a delivery configuration on a catheter, the trough not connected
to the peak. There will also be a plurality of connected peak-trough pairs along adjacent
serpentine circumferential bands, each connected peak-trough pair comprising a peak
on one serpentine circumferential band and a trough on the adjacent serpentine circumferential
band which is substantially circumferentially aligned with the peak when the stent
is in an unexpanded configuration, and desirably in a delivery configuration on a
catheter, the trough connected to the peak. The distance along a serpentine circumferential
band between each peak of a connected peak-trough pair and an adjacent peak of an
unconnected peak-trough pair differs from the distance along the adjacent serpentine
circumferential band between the trough of the connected-trough pair and an adjacent
trough of an unconnected peak-trough pair, the adjacent peak substantially opposite
the adjacent trough.
[0009] The invention is also directed to a stent, comprising a plurality of serpentine circumferential
bands comprising alternating peaks and troughs. Adjacent serpentine circumferential
bands are connected to one another. The serpentine circumferential bands include a
first serpentine circumferential band, a second serpentine circumferential band and
a third serpentine circumferential band. The first serpentine circumferential band
includes high peaks and low peaks. The second serpentine circumferential band includes
high peaks and low peaks, high troughs and low troughs. The third serpentine circumferential
band includes high troughs and low troughs. The high peaks of the first serpentine
circumferential band are substantially circumferentially aligned with the low troughs
of the second serpentine circumferential band and the low peaks of the first serpentine
circumferential band are substantially circumferentially aligned with the high troughs
of the second serpentine circumferential band. Also the high peaks of the second serpentine
circumferential band are substantially circumferentially aligned with the low troughs
of the third serpentine circumferential band and the low peaks of the second serpentine
circumferential band are substantially circumferentially aligned with the high troughs
of the third serpentine circumferential band. Desirably, the first serpentine circumferential
band is interlaced with the second serpentine circumferential band and the second
serpentine circumferential band is interlaced with the third serpentine circumferential
band.
[0010] Desirably, adjacent serpentine circumferential bands are connected to one another
via a plurality of longitudinal connectors extending between substantially circumferentially
aligned peaks and troughs.
[0011] Typically, there will be a plurality of unconnected peak-trough pairs, each unconnected
peak-trough pair comprising a peak on a serpentine circumferential band and a trough
on the serpentine circumferential band adjacent thereto which is substantially circumferentially
aligned with the peak when the stent is in an unexpanded configuration, and desirably
in a delivery configuration on a catheter, the trough not connected to the peak. There
will also be a plurality of connected peak-trough pairs, each connected peak-trough
pair comprising a peak on a serpentine circumferential band and a trough on the serpentine
circumferential band adjacent thereto which is substantially circumferentially aligned
with the peak when the stent is in an unexpanded configuration, and desirably in a
delivery configuration on a catheter, the trough connected to the peak. The distance
along the serpentine circumferential band between each peak of a connected peak-trough
pair and an adjacent peak of an unconnected peak-trough pair differs from the distance
along the adjacent serpentine circumferential band between the trough of the connected-trough
pair and an adjacent trough of an unconnected peak-trough pair, the adjacent peak
substantially opposite the adjacent trough.
[0012] As the stent expands, peaks and troughs of unconnected peak-trough pairs are displaced
relative to one another about the circumference of the stent.
[0013] The invention is also directed to a stent having a proximal end and a distal end
comprising a plurality of connected serpentine circumferential bands. Each serpentine
band comprises a plurality of struts arranged in alternating peaks and troughs. Adjacent
serpentine circumferential bands are connected via a plurality of longitudinal connectors
extending between peaks on one serpentine circumferential band and troughs on the
serpentine circumferential band adjacent thereto. The struts of the serpentine bands
are arranged such that on expansion of the stent, peaks and troughs which are substantially
circumferentially aligned with one another, but not connected with one another, on
adjacent serpentine circumferential bands are circumferentially displaced from one
another. Typically, each band comprises a repeating pattern of three or more struts
of different lengths. The struts of different lengths are also typically of different
widths. Desirably, the stent is constructed and arranged to be self-expanding.
[0014] The invention is also directed to a stent comprising at least one circumferential
serpentine band disposed about a longitudinal axis, the serpentine band comprising
a plurality of struts, adjacent struts connected one to the other, the serpentine
band having alternating peaks and troughs, the serpentine band including at least
three peaks which are circumferentially and longitudinally offset from one another.
Typically, the stent will comprise a plurality of the circumferential serpentine band,
adjacent circumferential serpentine bands connected to one another. Desirably, adjacent
circumferential serpentine bands are connected to one another via two or more longitudinal
connectors. More desirably, the stent is constructed such that unconnected peaks and
troughs which are substantially circumferentially aligned prior to expansion of the
stent are circumferentially displaced from one another on expansion of the stent.
[0015] The invention is also directed to a stent comprising at least one serpentine circumferential
band which comprises a repeat pattern of three or more struts of different lengths.
Desirably, the stent comprises a plurality of the serpentine band, adjacent bands
connected to one another. The struts are arranged in a pattern of alternating peaks
and troughs.
[0016] The invention is also directed to a stent comprising at least two serpentine bands
including a first serpentine band and a second serpentine band, each serpentine band
having alternating peaks and troughs, the first serpentine band including connected
peaks and unconnected peaks, the second serpentine band including connected troughs
and unconnected troughs. The peaks of the first serpentine band are substantially
longitudinally aligned with the troughs of the second serpentine band when the stent
is in an unexpanded state, and desirably in a delivery configuration on a catheter.
The connected peaks are connected to the connected troughs with connectors, each of
the connectors having two ends which are substantially circumferentially aligned with
one another in an unexpanded state, and desirably in a delivery configuration on a
catheter. The unconnected peaks of each band become circumferentially displaced from
the unconnected troughs of an adjacent serpentine circumferential band, and the unconnected
troughs of each serpentine circumferential band become circumferentially displaced
from the unconnected peaks of each serpentine circumferential band on expansion of
the stent.
[0017] The invention is also directed to a stent comprising at least two serpentine bands
including a first serpentine band and a second serpentine band. Each serpentine band
has alternating peaks and troughs. The first serpentine band includes connected peaks
and unconnected peaks, and the second serpentine band includes connected troughs and
unconnected troughs. The first and second serpentine bands have an identical number
of peaks. The peaks of the first serpentine band are substantially longitudinally
aligned with the troughs of the second serpentine band when the stent is in an unexpanded
state. The connected peaks are connected to the connected troughs. The unconnected
peaks of each band become circumferentially displaced from the unconnected troughs
of an adjacent band, and the unconnected troughs of each band become circumferentially
displaced from the unconnected peaks of an adjacent band on expansion of the stent.
[0018] Desirably, the stent comprises a third serpentine band having alternating peaks and
troughs. The first, second and third serpentine bands are arranged sequentially along
the stent with the first serpentine band and the second serpentine band connected
one to the other and defining a plurality of cells therebetween and the second serpentine
band and the third serpentine band connected one to the other and defining a plurality
of cells therebetween. The first, second and third serpentine bands have the same
number of peaks.
[0019] More desirably, the stent has a first and second end region and a middle region extending
therebetween wherein at least one of the first and second end regions of the stent
has a different cell structure from the remainder of the stent. Optionally, the first
and second end regions may have a cell structure which differs from one another.
[0020] Additional details and/or embodiments of the invention are discussed below.
Brief Description of the Figures
[0021]
Fig. 1a shows a flat view of an inventive stent.
Fig. 1b shows a flat view of an inventive stent.
Fig. 1c shows an enlarged view of a portion of the inventive stent of Fig. 1b.
Fig. 2 shows a flat view of an inventive stent.
Fig. 3 shows a flat view of an inventive stent.
Fig. 4 shows a flat view of an inventive stent in an unexpanded configuration.
Fig. 5 shows a flat view of the stent of Fig. 4 in an expanded configuration.
Fig. 6a shows a flat view of another inventive stent.
Fig. 6b shows an enlarged end portion of the stent of Fig. 6a.
Detailed Description of the Invention
[0022] This invention may be embodied in many different forms. This description is an exemplification
of the principles of the invention and is not intended to limit the invention to the
particular embodiments illustrated.
[0023] For the purposes of this disclosure, unless otherwise indicated, identical reference
numerals used in different figures refer to the same component.
[0024] Also, the phrase 'substantially circumferentially aligned' as used herein does not
require perfect circumferential alignment. Rather, it requires that at least a portion
of a peak be circumferentially aligned with a portion of a trough on an adjacent serpentine
circumferential band. Examples of substantially circumferentially aligned peaks and
troughs include but are not limited to facing peak 16' and trough 18' connected by
longitudinal connector 24 shown in Figs. 1a, 2 and 3 and facing peak 16b' and trough
18b' connected by longitudinal connector 24 shown in Fig. 5, as well as facing peak
16" and trough 18" shown in the circled regions of Figs. 1-3.
[0025] Further, the term 'longitudinally staggered' when used in reference to peaks or troughs
within a serpentine circumferential band refers to peaks or troughs with the band
which extend to different positions lengthwise along the length of the stent. Examples
of longitudinally staggered peaks within a serpentine circumferential band include
but are not limited to peaks 16' and 16" within a band as shown in Figs. 1-3. Examples
of longitudinally staggered troughs within a serpentine circumferential band include
but are not limited to troughs 18' and 18" within a band as shown in Figs. 1-3. Longitudinally
aligned peaks or troughs extend to the same location lengthwise along the stent. Examples
of longitudinally aligned peaks or troughs are shown in the proximal end and distal
ends of the stent of Fig. 2. Other examples include all peaks 16' within a serpentine
band.
[0026] The term 'distal' as used herein in reference to the distal end of a stent refers
to the end of the stent which is inserted first into the body. The term 'proximal'
as used herein in reference to the proximal end of a stent refers to the end of the
stent which is inserted last into the body. It is within the scope of the invention
that the orientation of any of the inventive stents disclosed herein can be reversed
so that either end may be delivered into the body first.
[0027] In Fig. 1a, a flat view of an inventive stent is shown. The stent has a distal end
10 and a proximal end 12 and comprises a plurality of serpentine circumferential bands
20. Each band comprises a plurality of interconnected struts and includes struts of
three different lengths. As shown, the first strut 14a is shorter and narrower than
second strut 14b and third strut 14c. Third strut 14c is longer and wider that first
strut 14a and second strut 14b. The struts 14a-c are arranged in a repeating pattern
such that the circumferentially adjacent peaks 16 within each band 20 terminate at
different longitudinal points along the stent and the circumferentially adjacent troughs
18 within each band 20 terminate at different longitudinal points along the stent.
[0028] Adjacent serpentine circumferential bands are connected to one another in at least
one and desirably, as shown in Fig. 1a, a plurality of locations. In the stent of
Fig. 1a, the connections between adjacent serpentine circumferential bands are in
the form of longitudinal connectors 24 which extend between peaks 16 on one band and
substantially circumferentially aligned troughs 18 on an adjacent band.
[0029] Desirably, circumferentially adjacent connectors 20 are separated by a path along
one serpentine circumferential band which traverses at least two peaks of the serpentine
circumferential band and by a path along the adjacent serpentine circumferential band
which traverses at least two troughs of the adjacent serpentine circumferential band.
The invention allows for more peaks or fewer and/or more troughs or fewer troughs
between adjacent connectors of any of the embodiments disclosed herein.
[0030] The stent is further constructed so that in the unexpanded configuration, and desirably
in a delivery configuration, peaks of one serpentine circumferential band are substantially
circumferentially aligned with troughs of an adjacent serpentine circumferential band.
[0031] Because of the unequal strut pair lengths of strut pairs which are opposite one another
on adjacent serpentine circumferential bands, on expansion of the stent unconnected
peaks and troughs which were substantially circumferentially aligned with one another
will be displaced circumferentially relative to one another.
[0032] In another embodiment of the invention, as shown in the flat in Fig.1b, adjacent
serpentine circumferential bands 20 are interconnected via a plurality of connectors
24 whose first and second ends are circumferentially and longitudinally offset from
one another. Desirably, as shown in Fig. 1b, connectors 24 are substantially linear.
Non-linear connectors, including curved connectors, connectors having curved portions
and connectors having angled portions, may also used if space permits. Connectors
24 may be seen in greater detail in Fig. 1c which is an enlargement of a portion of
the stent of Fig. 1b. The connectors are shown with hatch marks in Fig. 1c. Although
connectors 24 are at an oblique angle relative to the longitudinal axis of the stent,
they are, nevertheless, substantially parallel to the longitudinal axis of the stent.
It is within the of the invention to provide embodiments in which connectors 24 are
disposed at a more substantial angle relative to the longitudinal axis of the stent
so that the connectors are not substantially parallel to the longitudinal axis of
the stent. The connectors of Fig. 1b may also be longer, depending on the separation
between adjacent serpentine circumferential bands.
[0033] In other respects, the stent of Figs. 1b and 1c is similar to that of Fig. 1a. Both
stents have three types of struts 14a-14c of increasing length and width. Both have
connected pairs of peaks and trough 16' and 18' as well as unconnected pairs of substantially
circumferentially aligned and unconnected peaks 16" and troughs 18". In both stents,
the struts are distributed such that on expansion of the stent, unconnected but substantially
circumferentially aligned peaks and troughs are displaced relative to one another
about the circumference of the stent.
[0034] In another embodiment of the invention, as shown in the flat in Fig. 2, each serpentine
circumferential band comprises three types of struts of different length, struts 14a-14c.
[0035] With the exception of the distal-most serpentine circumferential band, within a serpentine
circumferential band, the peaks are arranged circumferentially in a repeat pattern
of two longitudinally aligned adjacent peaks and one shorter peak adjacent to the
two aligned peaks. Also, with the exception of the proximal-most serpentine circumferential
band, within a serpentine circumferential band, the troughs are arranged circumferentially
in a repeat pattern of two longitudinally aligned adjacent troughs and one longer
trough adjacent to the two aligned troughs.
[0036] As with the stent of Fig. 1a, the struts within the serpentine circumferential bands
are arranged such that when the stent is in an unexpanded state, peaks on one band
are substantially circumferentially aligned with troughs on an adjacent substantially
circumferential band. Upon expansion of the stent, peaks and troughs which were substantially
circumferentially aligned with one another will be displaced circumferentially relative
to one another.
[0037] The proximal-most and distal-most serpentine circumferential bands of the stent of
Fig. 2 differ from that of Fig. 1a in that the troughs of the proximal-most serpentine
circumferential band are aligned with another and the peaks of the distal-most serpentine
circumferential band are aligned with another, unlike in the stent of Fig. 1a. Moreover,
the peaks in the proximal-most serpentine circumferential band are arranged in a repeating
pattern of two longer peaks followed by one shorter peak and the troughs in the distal-most
serpentine circumferential band are arranged in a repeating pattern of one longer
trough and two shorter troughs.
[0038] The stent of Fig. 2 is similar to the stent of Fig. 1a in that the number of connections
between the adjacent serpentine circumferential bands is constant along the length
of the stent. Also, the frequency of connections between the adjacent serpentine circumferential
bands is constant along the length of the stent as is the spacing of the connections
about the circumference of the stent.
[0039] Another inventive stent is shown in Fig. 3. The stent of Fig. 3 is similar to the
stent of Fig, 2 but differs in that troughs in the proximal-most serpentine circumferential
band are not longitudinally aligned with one another. Also, the peaks in the distal-most
serpentine circumferential band are not longitudinally aligned with one another. Rather,
the proximal-most and distal-most serpentine circumferential bands of the stent are
of the same construction as the remainder of the serpentine circumferential bands
in the stent.
[0040] Fig. 4 shows a flat view of an inventive stent in an unexpanded configuration. In
this figure the unconnected peaks 16" of each band proximal to the distal most band
are substantially circumferentially aligned with the unconnected troughs 18" of an
adjacent band 20. The struts 14a-c are of three lengths and widths. The stent of Fig.
4 is shown in an expanded configuration in Fig. 5. In the expanded configuration,
unconnected peaks 16" and unconnected troughs 18" which were previously substantially
circumferentially aligned with one another are now displaced circumferentially, relative
to one another. A similar circumferential displacement between unconnected but substantially
circumferentially aligned peaks and troughs occurs in the other stents disclosed herein
as well.
[0041] An inventive stent with special ends is shown in the flat in Figs. 6a and 6b. Unlike
with the stents of the previous figures, the stent of Figs. 6a and 6b has an increased
number of connectors extending between adjacent serpentine circumferential bands at
the ends of the stent. Specifically, each peak on the proximal-most serpentine circumferential
band is connected to a trough on the adjacent serpentine circumferential band and
each trough on the distal-most serpentine circumferential band is connected to a peak
on the adjacent serpentine circumferential band. The connectivity results in plurality
of larger and smaller substantially diamond-shaped cells 25a and 25b (shown with hatching)
which serves to stabilize the end of the stent.
[0042] The stent of Figs. 6a and 6b may be modified in numerous ways. In one modification,
only one end of the stent is provided with the additional connectors so that only
one end of the stent has the large cell/small cell structure shown in Figs. 6a and
6b. In another modification, at one or both ends of the stent three or more adjacent
serpentine circumferential bands are interconnected with additional or fewer connectors
as compared with the remainder of the stent. Thus, the resulting stent has multiple
adjacent rows of large and small diamond cells at one or both ends of the stent. Also,
the ratio of connectors to peaks may be other than the 1:1 ratio provided at the end
of the stent of Fig. 6a and other than the ratio of 1:3 provided in Fig. 1a.
[0043] The stent of Fig. 1a is designed such that the expansion proceeds in the same way
whether the stent is deployed from the proximal to the distal end or vice versa. The
stents of Figs. 2-6, on the other, expand differently depending on whether the stent
is expanded from the proximal to the distal end or vice versa.
[0044] In the middle serpentine circumferential bands of the stent of Fig. 2, deployment
from the distal end 10 of the stent results in the deployment of the unconnected peaks
16" of each serpentine circumferential band 20 before the deployment of the connected
peaks 16'. Deployment from the proximal end 12 of the stent results in the deployment
of the connected troughs 18' of each band 20 before the deployment of the unconnected
troughs 18".
[0045] In the inventive stents disclosed herein, each serpentine circumferential band is
characterized by a path length about the periphery of the stent. This path length
corresponds to the length that the band would have if cut open and stretched out into
a line. Desirably, as shown in Figs. 1-6, each of the serpentine circumferential bands
is of the same total pathlength. The invention also contemplates embodiment in which
the serpentine bands are not all of the same pathlength. To the extent that the stent
has pathlengths of different length, the different length pathways are desirably provided
only at one or both ends of the stent.
[0046] In the inventive stents disclosed in Figs. 1-6, the serpentine circumferential bands
all have the same number of peaks and the same number of troughs. Although the invention
also contemplates embodiments which include bands of different numbers of peaks and
troughs, to the extent that such bands are present, it is desirable that they be present
only at one or both ends of the stent.
[0047] To the extent that the stents of Figs. 1-6 are considered to comprise serpentine
circumferential bands, each of which comprises a plurality of interconnected struts,
it is noted that all of the bands have the same number of struts. The invention also
contemplates embodiments having the presence of some serpentine circumferential bands
which have more or fewer struts than other of the serpentine circumferential bands.
Desirably, however, the bands having different numbers of struts are provided only
at one or both ends of the stent.
[0048] The inventive stents may also be considered to compromise a plurality of interconnected
cells. As shown in Fig. 1a, the stent comprises a plurality of rows of interconnected
cells 27' and 27". Cells 27' and 27"are identical in area and shape but extend in
opposite helical directions about the longitudinal axis of the stent. Each cell is
defined by first and second paths which are connected to one another by connectors.
Cell 27' for example, has a first path 31' and a second path 33' connected by connectors
24. The first path forms a part of a serpentine circumferential band and the second
path form a part of another serpentine circumferential band. In the embodiment of
Figs. 1-6, the first and second paths at the ends of a cell are of the same pathlength.
The first and second paths of a cell also have the same number of struts. However,
the arrangement of the struts in the first and second paths differ from one another
resulting in peak-trough pairs within a cell which are substantially circumferentially
aligned in an unexpanded state and desirably in a delivery configuration on a catheter
and which are circumferentially displaced relative to one another on expansion of
the stent.
[0049] In the embodiment of Fig. 1b, cells 27' and 27" are oriented in opposite helical
directions about the longitudinal axis of the stent. In the embodiment of Fig. 2,
three types of cells 27', 27" and 27"' are present as a result of the alignment of
the peaks at one end and the troughs at the other end of the stent. In the embodiments
of Figs. 3 and 4, only a single type of cell 27' is present. In the embodiment of
Figs 6a and 6b, cells 25a and 25b at the ends of the stent are substantially diamond
shape whereas the remaining cells 27' are not substantially diamond shaped.
[0050] The inventive stents of Figs. 1-6 allow for pairs of unconnected peaks and troughs
on adjacent bands to be substantially aligned in an unexpanded state, and desirably
in the delivery configuration, while allowing for the unconnected peaks and troughs
to be displaced circumferentially relative to one another on expansion of the stent.
This is achieved, using serpentine circumferential bands of equal path length and/or
equal numbers of peaks, by arranging the struts of the stent such that the path length
between a connected peak and a circumferentially adjacent connected peak on a first
serpentine band is different from the path length along an adjacent serpentine band
between the corresponding connected trough and the corresponding unconnected trough.
Differently stated, the summed length of the two struts immediately circumferentially
adjacent to a connected peak is different than the summed length of the two struts
immediately adjacent the corresponding connected trough as the circumference of the
stent is traversed in a given direction. By employing bands with the same number of
peaks to achieve the displacement on expansion of the stent, the use of connectors
which are substantially angled relative to the longitudinal axis may be avoided. Moreover,
more uniform coverage of the vessel may be achieved as compared with stents having
bands of differing numbers of peaks.
[0051] The invention is also directed to a stent having a proximal end and a distal end
comprising a plurality of connected serpentine circumferential bands. Each serpentine
band comprises a plurality of struts arranged in alternating peaks and troughs. Adjacent
serpentine circumferential bands are connected via a plurality of longitudinal connectors
extending between peaks on one serpentine circumferential band and troughs on the
serpentine circumferential band adjacent thereto. The struts of the serpentine bands
are arranged such that on expansion of the stent, peaks and troughs which are substantially
circumferentially aligned with one another, but not connected with one another, on
adjacent serpentine circumferential bands are circumferentially displaced from one
another. Typically, each band comprises a repeating pattern of three or more struts
of different lengths. The struts of different lengths are also typically of different
widths. Desirably, the stent is constructed and arranged to be self-expanding.
[0052] The invention is also directed to a stent comprising at least one circumferential
serpentine band disposed about a longitudinal axis, the serpentine band comprising
a plurality of struts, adjacent struts connected one to the other, the serpentine
band having alternating peaks and troughs, the serpentine band including at least
three peaks which are circumferentially and longitudinally offset from one another.
Typically, the stent will comprise a plurality of the circumferential serpentine band,
adjacent circumferential serpentine bands connected to one another. Desirably, adjacent
circumferential serpentine bands are connected to one another via two or more longitudinal
connectors. More desirably, the stent is constructed such that unconnected peaks and
troughs which are substantially circumferentially aligned prior to expansion of the
stent are circumferentially displaced from one another on expansion of the stent.
[0053] The invention is also directed to a stent comprising at least one serpentine circumferential
band which comprises a repeat pattern of three or more struts of different lengths.
Desirably, the stent comprises a plurality of the serpentine band, adjacent bands
connected to one another. The struts are arranged in a pattern of alternating peaks
and troughs.
[0054] The invention is also directed to a stent comprising at least two serpentine bands
including a first serpentine band and a second serpentine band, each serpentine band
having alternating peaks and troughs, the first serpentine band including connected
peaks and unconnected peaks, the second serpentine band including connected troughs
and unconnected troughs. The peaks of the first serpentine band are substantially
longitudinally aligned with the troughs of the second serpentine band when the stent
is in an unexpanded state. The connected peaks are connected to the connected troughs
with connectors, each of the connectors having two ends which are substantially longitudinally
aligned with one another in at least the unexpanded state. The unconnected peaks of
each band become circumferentially displaced from the unconnected troughs of an adjacent
serpentine circumferential band, and the unconnected troughs of each serpentine circumferential
band become circumferentially displaced from the unconnected peaks of each serpentine
circumferential band on expansion of the stent.
[0055] The invention is also directed to a stent comprising at least two serpentine bands,
such as that shown by way of non-limiting example in Figs. 6a and 6b, including a
first serpentine band and a second serpentine band. Each serpentine band has alternating
peaks and troughs. The first serpentine band includes connected peaks and unconnected
peaks, and the second serpentine band includes connected troughs and unconnected troughs.
The first and second serpentine bands have an identical number of peaks. The peaks
of the first serpentine band are substantially longitudinally aligned with the troughs
of the second serpentine band when the stent is in an unexpanded state. The connected
peaks are connected to the connected troughs. The unconnected peaks of each band become
circumferentially displaced from the unconnected troughs of an adjacent band, and
the unconnected troughs of each band become circumferentially displaced from the unconnected
peaks of an adjacent band on expansion of the stent. Optionally, the first and second
serpentine bands may be of different total pathlength about the stent.
[0056] Desirably, as shown in Fig. 6a, the stent comprises a third serpentine band having
alternating peaks and troughs. The first, second and third serpentine bands are arranged
sequentially along the stent with the first serpentine band and the second serpentine
band connected one to the other and defining a plurality of cells therebetween and
the second serpentine band and the third serpentine band connected one to the other
and defining a plurality of cells therebetween. The first, second and third serpentine
bands have the same number of peaks.
[0057] More desirably, as shown in Figs. 6a and 6b, the stent has a first and second end
region and a middle region extending therebetween wherein at least one of the first
and second end regions of the stent has a different cell structure from the remainder
of the stent. Optionally, the first and second end regions may have a cell structure
which differs from one another.
[0058] The invention is also directed to helical stents. One or more helical bands may be
provided where the peaks and troughs on it are arranged such that some of the peaks
are substantially circumferentially aligned and connected to some of the troughs on
an adjacent turn of the helical band or on an adjacent helical band and other substantially
circumferentially aligned peaks and troughs on adjacent bands or adjacent turns of
a band are not connected to one another. On expansion of the stent, the non-connected
substantially circumferentially aligned peaks and troughs are circumferentially displaced
from one another. This may be achieved with an appropriate arrangement of struts.
[0059] Any of the inventive stents disclosed herein may also be provided in a 'jelly roll'
configuration. For example, the flat pattern of Fig. 1 may be rolled into a tube without
securing the longitudinal edges to one another. Such a stent would be deployed by
unrolling and expansion of the cells or bands which extend about the longitudinal
axis of the stent. An example of such a stent is disclosed in
WO0132099.
[0060] The inventive stents disclosed herein may also be provided in an embodiments in which
the longitudinal connectors may be shorter or longer than those shown in Fig. 1a or
any of the other figures disclosed herein. For example, in one embodiment, where adjacent
bands have the same number of peaks, facing peaks and troughs which are connected
to one another may abut one another and the connector may be in the form of a small
weld or an overlap region between the facing peak and trough. Also, connector which
are curved may be used to connect facing peaks and troughs. The connectors may also
be located offset from the peaks and troughs.
[0061] The invention is also directed to stents such as those disclosed herein with sidebranch
access. Such a stent may be provided by omitting one or more struts in one or more
desired regions of the stent. Sidebranch access may also be provided by omitting a
first serpentine band and providing connectors between some, but not all of the peaks
and troughs of the resulting adjacent second serpentine bands. Sidebranch access may
further be achieved in any of the inventive stents disclosed herein by alternating
the location of connectors between adjacent serpentine bands. For example, where it
is desirable to provide for sidebranch access, fewer connections between adjacent
bands may be provided. Sidebranch access may also be provided by including adjacent
serpentine bands of different total pathlength. In such a case, it is desirable although
not necessary that the adjancent serpentine bands have the same number of peaks.
[0062] The inventive stents disclosed herein may also be used in bifurcated stents. The
trunk and/or any of the branches may be provided with stents having the novel designs
disclosed herein.
[0063] Any of the inventive stents disclosed above may be provided with a uniform diameter
or may taper in portions or along the entire length of the stent. Also, the width
and/or thickness of the various portions of the inventive stents may increase or decrease
along a given portion of the stent. For example, the width and/or thickness of the
struts, serpentine bands and/or longitudinal connectors may increase or decrease along
portions of the stent or along the entire length of the stent. The amplitude and/or
wavelength of several successive first serpentine bands may remain constant while
the width and/or thickness of the successive first serpentine bands decreases. Similarly,
the amplitude and/or wavelength of several successive second serpentine bands may
remain constant while the width and/or thickness of the successive second serpentine
bands decreases. In other embodiments of the inventive stents disclosed herein, the
amplitude and/or wavelength of several successive first serpentine bands may decrease
or increase while the width and/or thickness of the successive first serpentine bands
remains constant. Similarly, the amplitude and/or wavelength of several successive
second serpentine bands may or decrease or increase while the width and/or thickness
of the successive second serpentine bands remain constant. The amplitude of the stent
could also be increased or decrease along with the thickness and/or width of the stent.
[0064] The inventive stents may be manufactured using known stent manufacturing techniques.
Suitable methods for manufacturing the inventive stents include laser cutting, chemical
etching or stamping of a tube. The inventive stents may also be manufactured by laser
cutting, chemically etching, stamping a flat sheet, rolling the sheet and welding
the sheet, by electrode discharge machining, or by molding the stent with the desired
design.
[0065] Any suitable stent material may be used in the manufacture of the inventive stents.
Examples of such materials include polymeric materials, metals, ceramics and composites.
Suitable polymeric materials include thermotropic liquid crystal polymers (LCP's).
Where the stent is made of metal, the metal may be stainless steel, cobalt chrome
alloys such as elgiloy, tantalum or other plastically deformable metals. Other suitable
metals include shape-memory metals such as nickel titanium alloys generically known
as "nitinol", platinum/tungsten alloys and titanium alloys. The invention also contemplates
the use of more than one material in the inventive stents. For example, the first
serpentine band and the second serpentine band may be made of different materials.
Optionally, the connectors may be made of a different material than the first and/or
second serpentine bands.
[0066] The inventive stents desirably are provided in self-expanding form. To that end,
they may be constructed from shape memory materials including Nitinol. The self-expanding
embodiments of the invention allow for a controlled expansion of the stent as explained
below. Typically, self-expanding stents are restrained on a catheter in an unexpanded
configuration via a sheath. As the sheath is withdrawn, the newly freed portions of
the stent will self-expand. Because the peaks within a serpentine cylindrical bands
extend to different longitudinal extent, each serpentine circumferential band will
be freed from the sheath in several waves - the first wave of peaks, corresponding
to the longest peaks will expand first, followed by a wave of peaks which are shorter
expanding until the serpentine is expanded.
[0067] The inventive stents may also be provided in balloon expandable form, or as a hybrid,
having self-expanding characteristics and balloon expandable characteristics.
[0068] The inventive stents may include suitable radiopaque coatings. For example, the stents
may be coated with gold or other noble metals or sputtered with tantalum or other
metals. The stents may also be made directly from a radiopaque material to obviate
the need for a radiopaque coating or may be made of a material having a radiopaque
inner core. Other radiopaque metals which may be used include platinum, platinum tungsten,
palladium, platinum iridium, rhodium, tantalum, or alloys or composites of these metals.
[0069] The inventive stents may also be provided with various bio-compatible coatings to
enhance various properties of the stent. For example, the inventive stents may be
provided with lubricious coatings. The inventive stents may also be provided with
drug-containing coatings which release drugs over time.
[0070] The inventive stents may also be provided with a sugar or more generally a carbohydrate
and/or a gelatin to maintain the stent on a balloon during delivery of the stent to
a desired bodily location. Other suitable compounds for treating the stent include
biodegradable polymers and polymers which are dissolvable in bodily fluids.
[0071] Portions of the interior and/or exterior of the stent may be coated or impregnated
with the compound. Mechanical retention devices may also be used to maintain the stent
on the balloon during delivery.
[0072] The inventive stents may also be used as the framework for a graft or may have a
liner disposed therein. Suitable coverings and liners include nylon, collagen, PTFE
and expanded PTFE, polyethylene terephthalate and KEVLAR, or any of the materials
disclosed in
US 5,824,046 and
US 5,755,770. More generally, any known graft material may be used including synthetic polymers
such as polyethylene, polypropylene, polyurethane, polyglycolic acid, polyesters,
polyamides, their mixtures, blends, copolymers, mixtures, blends and copolymers.
[0073] The inventive stents may find use in coronary arteries, renal arteries, peripheral
arteries including illiac arteries, arteries of the neck and cerebral arteries. The
stents of the present invention, however, are not limited to use in the vascular system
and may also be advantageously employed in other body structures, including but not
limited to arteries, veins, biliary ducts, urethras, fallopian tubes, bronchial tubes,
the trachea, the esophagus and the prostate.
[0074] The invention is also directed to stent delivery catheters with stents such as those
disclosed herein disposed about a portion of the catheter.
[0075] The invention is also directed to methods of delivering any of the stents disclosed
herein. The methods comprise delivering a catheter with an inventive stent disclosed
herein disposed thereabout to a desired bodily location and expanding the stent or
allowing the stent to expand. In the latter case, the stent is self-expanding and
a sheath which restrains the stent is removed from about the stent. As the sheath
is removed, waves of peaks from a given serpentine circumferential band are freed
to self-expand. Upon deployment of the stent, the catheter is removed from the body.
[0076] The above disclosure is intended to be illustrative and not exhaustive. This description
will suggest many variations and alternatives to one of ordinary skill in this art.
All these alternatives and variations are intended to be included within the scope
of the claims where the term "comprising" means "including, but not limited to". Those
familiar with the art may recognize other equivalents to the specific embodiments
described herein which equivalents are also intended to be encompassed by the claims.
[0077] The above Examples and disclosure are intended to be illustrative and not exhaustive.
These examples and this description will suggest many variations and alternatives
to one of ordinary skill in this art. All these alternatives and variations are intended
to be included within the scope of the attached claims. Those familiar with the art
may recognize other equivalents to the specific embodiments described herein which
equivalents are also intended to be encompassed by the claims attached hereto.
1. Stent, umfassend:
eine Vielzahl von serpentinenförmigen umlaufenden Streifen, umfassend alternierende
Gipfel und Mulden, wobei benachbarte serpentinenförmige umlaufende Streifen miteinander
verbunden sind und die serpentinenförmigen umlaufenden Streifen einen ersten serpentinenförmigen
umlaufenden Streifen, einen zweiten serpentinenförmigen umlaufenden Streifen und einen
dritten serpentinenförmigen umlaufenden Streifen beinhalten,
wobei der erste serpentinenförmige umlaufende Streifen hohe Gipfel und niedrige Gipfel
beinhaltet,
der zweite serpentinenförmige umlaufende Streifen hohe Gipfel und niedrige Gipfel,
hohe Mulden und niedrige Mulden beinhaltet,
der dritte serpentinenförmige umlaufende Streifen hohe Mulden und niedrige Mulden
beinhaltet,
die hohen Gipfel des ersten serpentinenförmigen umlaufenden Streifens im wesentlichen
in der Umfangsrichtung parallel zu den niedrigen Mulden des zweiten serpentinenförmigen
umlaufenden Streifens ausgerichtet sind und die niedrigen Gipfel des ersten serpentinenförmigen
umlaufenden Streifens im wesentlichen in der Umfangsrichtung parallel zu den hohen
Mulden des zweiten serpentinenförmigen umlaufenden Streifens ausgerichtet sind,
die hohen Gipfel des zweiten serpentinenförmigen umlaufenden Streifens im wesentlichen
in der Umfangsrichtung parallel zu den niedrigen Mulden des dritten serpentinenförmigen
umlaufenden Streifens ausgerichtet sind und
die niedrigen Gipfel des zweiten serpentinenförmigen umlaufenden Streifens im wesentlichen
in der Umfangsrichtung parallel zu den hohen Mulden des dritten serpentinenförmigen
umlaufenden Streifens ausgerichtet sind,
dadurch gekennzeichnet, dass
der erste serpentinenförmige umlaufende Streifen (20) eine Vielzahl von ineinander
geschachtelten Gipfeln (16) beinhaltet, deren jeder sich zwischen mindestens zwei
Mulden (18) des zweiten serpentinenförmigen umlaufenden Streifens (20) befindet und
der zweite serpentinenförmige umlaufende Streifen (20) eine Vielzahl von ineinander
geschachtelten Gipfeln (16) beinhaltet, deren jeder sich zwischen mindestens zwei
Mulden (18) des dritten serpentinenförmigen umlaufenden Streifens (20) befindet.
2. Stent gemäß Anspruch 1, so konstruiert und angeordnet, dass er selbstexpandierend
ist.
3. Stent gemäß Anspruch 1, ferner umfassend mindestens einen Endstreifen, wobei der Endstreifen
in der Form eines serpentinenförmigen Streifens (20) ist, dessen Gipfel (16) oder
Mulden (18) alle in Längsrichtung parallel zueinander ausgerichtet sind.
4. Stent gemäß Anspruch 1, ferner umfassend zwei Endstreifen, einen proximalen Endstreifen
und einen distalen Endstreifen, wobei der proximale Endstreifen in der Form eines
serpentinenförmigen Streifens (20) mit alternierenden Gipfeln (16) und Mulden (18)
ist, dessen Mulden alle in Längsrichtung parallel zueinander ausgerichtet sind, der
distale Endstreifen in der Form eines serpentinenförmigen Streifens (20) mit alternierenden
Gipfeln (16) und Mulden (18) ist, dessen Gipfel alle in Längsrichtung parallel zueinander
ausgerichtet sind
5. Stent gemäß Anspruch 1, wobei benachbarte serpentinenförmige umlaufende Streifen (20)
über eine Vielzahl von länglichen Verbindungselementen (24) miteinander verbunden
sind, die sich zwischen im wesentlichen in Umfangsrichtung parallel ausgerichteten
Gipfeln (16) und Mulden (18) erstrecken.
6. Stent gemäß Anspruch 1, in dem eine Vielzahl von unverbundenen Gipfel-Mulde-Paaren
vorhanden ist, wobei jedes unverbundene Gipfel-Mulde-Paar einen Gipfel (16) auf einem
serpentinenförmigen umlaufenden Streifen (20) und eine Mulde (18) auf dem dazu benachbarten
serpentinenförmigen umlaufenden Streifen (20) umfasst, welcher im wesentlichen in
der Umfangsrichtung parallel zu dem Gipfel (16) ausgerichtet ist, wenn der Stent in
einer nicht expandierten Konfiguration ist, wobei die Mulde (18) nicht mit dem Gipfel
(16) verbunden ist,
in dem eine Vielzahl von verbundenen Gipfel-Mulde-Paaren vorhanden ist, wobei jedes
verbundene Gipfel-Mulde-Paar einen Gipfel (16) auf einem serpentinenförmigen umlaufenden
Streifen (20) und eine Mulde (18) auf dem dazu benachbarten serpentinenförmigen umlaufenden
Streifen (20) umfasst, welcher im wesentlichen in der Umfangsrichtung parallel zu
dem Gipfel (16) ausgerichtet ist, wenn der Stent in einer nicht expandierten Konfiguration
ist, wobei die Mulde (18) mit dem Gipfel (16) verbunden ist,
wobei der Abstand entlang des serpentinenförmigen umlaufenden Streifens (20) zwischen
jedem Gipfel (16) eines verbundenen Gipfel-Mulde-Paares und einem benachbarten Gipfel
(16) eines unverbundenen Gipfel-Mulde-Paares sich von dem Abstand entlang des benachbarten
serpentinenförmigen umlaufenden Streifens (20) zwischen der Mulde (18) des verbundenen
Gipfel-Mulde-Paares und einer benachbarten Mulde (18) eines unverbundenen Gipfel-Mulde-Paares
unterscheidet und der benachbarte Gipfel (16) im wesentlichen gegenüber der benachbarten
Mulde (18) liegt.
7. Stent gemäß Anspruch 1, wobei die serpentinenförmigen umlaufenden Streifen (20) jeweils
aus einem sich wiederholenden Muster von Streben (14a, 14b, 14c) mindestens dreier
unterschiedlicher Längen aufgebaut sind.
1. Un stent, comprenant
une pluralité de bandes sinueuses circonférentielles, comprenant des sommets et des
creux alternants, des bandes sinueuses circonférentielles adjacentes raccordées l'une
avec l'autre, les bandes sinueuses circonférentielles incluant une première bande
sinueuse circonférentielle, une deuxième première bande sinueuse circonférentielle
et une troisième première bande sinueuse circonférentielle,
la première bande sinueuse circonférentielle incluant des sommets hauts et des sommets
bas,
la deuxième bande sinueuse circonférentielle incluant des sommets hauts et des sommets
bas et des creux hauts et bas,
la troisième bande sinueuse circonférentielle incluant des creux hauts et bas,
les sommets hauts de la première bande sinueuse circonférentielle étant essentiellement
circonférentiellement alignés avec les creux bas de la deuxième bande sinueuse circonférentielle
et les sommets bas de la première bande sinueuse circonférentielle étant essentiellement
circonférentiellement alignés avec les creux hauts de la deuxième bande sinueuse circonférentielle,
les sommets hauts de la deuxième bande sinueuse circonférentielle étant essentiellement
circonférentiellement alignés avec les creux bas de la troisième bande sinueuse circonférentielle,
et
les sommets bas de la deuxième bande sinueuse circonférentielle étant essentiellement
circonférentiellement alignés avec les creux hauts de la troisième bande sinueuse
circonférentielle,
caractérisé en ce que la première bande sinueuse circonférentielle (20) inclut une pluralité des sommets
(16) entrecroisés, chacun d'eux étant positionné entre au moins deux creux (18) de
la deuxième bande sinueuse circonférentielle (20) et que la deuxième bande sinueuse
circonférentielle (20) inclut une pluralité des sommets (16) entrecroisés, chacun
d'eux étant positionné entre au moins deux creux (18) de la troisième bande sinueuse
circonférentielle (20).
2. Le stent selon la revendication 1, construit et arrangé d'être à expansion automatique.
3. Le stent selon la revendication 1, comprenant en outre au moins une bande de bout,
la bande de bout étant dans la forme d'une bande sinueuse (20), dont les sommets (16)
ou les creux (18) sont tous alignés longitudinalement l'un avec l'autre.
4. Le stent selon la revendication 1, comprenant en outre deux bandes de bout, une bande
de bout proximale et une bande de bout distale, la bande de bout proximale étant dans
la forme d'une bande sinueuse (20) avec des sommets (16) et des creux (18) alternants,
dont les creux sont tous longitudinalement alignés l'un avec l'autre, la bande de
bout distale étant dans la forme d'une bande sinueuse (20) avec des sommets (16) et
des creux (18) alternants, dont les sommets sont tous longitudinalement alignés l'un
avec l'autre.
5. Le stent selon la revendication 1, dans lequel des bandes sinueuses circonférentielles
adjacentes (20) sont raccordées l'une à l'autre par une pluralité de connecteurs longitudinaux
(24), qui s'étendent entre des sommets (16) et des creux (18) alignés essentiellement
circonférentiels.
6. Le stent selon la revendication 1, dans lequel il y a une pluralité de paires de sommet
et creux non raccordés, chacune paire de sommet et creux non raccordés comprenant
un sommet (16) dans une bande sinueuse circonférentielle (20) et un creux (18) dans
la bande sinueuse circonférentielle adjacente à celle ci, qui est essentiellement
aligné circonférentiellement avec le sommet (16) quand le stent est dans une configuration
non élargie, le creux (18) n'étant raccordé au sommet (16),
dans lequel il y a une pluralité de paires de sommet et creux raccordés, chacune paire
de sommet et creux raccordés comprenant un sommet (16) dans une bande sinueuse circonférentielle
(20) et un creux (18) dans la bande sinueuse circonférentielle adjacente à celle ci,
qui est essentiellement aligné circonférentiellement avec le sommet (16) quand le
stent est dans une configuration non élargie, le creux (18) étant raccordé au sommet
(16),
et dans lequel la distance le long de la bande sinueuse circonférentielle (20) entre
chaque sommet (16) d'une paire de sommet et creux raccordés et un sommet adjacent
(16) d'une paire de sommet et creux non raccordés est différente de la distance le
long de la bande sinueuse circonférentielle (20) adjacente entre le creux (18) de
la paire de sommet et creux raccordés et un creux adjacent (18) d'une paire de sommet
et creux non raccordés, le sommet (16) adjacent étant essentiellement opposé au creux
adjacent (18).
7. Le stent selon la revendication 1, dans lequel chaque bande sinueuse circonférentielle
(20) est construite d'un modèle répétant de contrefiches (14a, 14b, 14c) d'au moins
trois longueurs différentes.